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Comprehensive and up-to-date drug news for both consumers and healthcare professionals.

Health Highlights: July 21, 2017

Posted 3 days ago in Medical

Here are some of the latest health and medical news developments, compiled by the editors of HealthDay: Linkin Park Singer Chester Bennington Dead at 41 Chester Bennington, the lead singer of the rock band Linkin Park, has died at age 41 in what is being investigated as a possible suicide. The death was confirmed by Brian Elias, the chief of operations for the Los Angeles County coroner's office, The New York...

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Can't Get to the Gym? Work Out in Your Office!

Posted today in Medical

MONDAY, July 24, 2017 -- Making time for exercise during your workday can be difficult. The good news: There are ways to discreetly slip in a workout without ever leaving your office. The bad news: No more excuses for not moving. Try these easy exercises from Harvard Health and Truman State University to get started. The Chair Stand works your hips and thighs, and all you need is a sturdy desk chair (if yours is on...

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Most American Men Qualify as 'Overfat'

Posted today in Medical

MONDAY, July 24, 2017 -- Most American men are "overfat," and most American women are not far behind, a new study says. Overfat refers to having excess body fat that can pose a threat to health. And the study authors from Australia and New Zealand said it's a separate term from measures of body mass -- in other words, even normal-weight people can be overfat. The authors ask: Does your waist measure more than half...

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Meds by Monthly Injection Might Revolutionize HIV Care

Posted today in Medical

MONDAY, July 24, 2017 -- Getting a shot of medication to control HIV every month or two instead of having to take pills every day could transform the way the virus is kept at bay. New research suggests that injectable, long-acting antiretroviral therapy for HIV is as safe and effective as oral medications. The injection -- given every four or eight weeks -- includes the drugs cabotegravir and rilpivirine. "We have...

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One Stroke Raises Risk for Another, Even Years Later: Study

Posted today in Medical

MONDAY, July 24, 2017 -- Your risk of a second stroke or ministroke remains considerable for at least five years after the first one, a new Canadian study finds. "We showed that, even in those survivors who had no complications at all after their stroke, their risk did not return to normal," said researcher Jodi Edwards. Patients were still at seven times higher risk of having a second stroke one year later, and...

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GSK Receives FDA Approval for a New Self-Injectable Formulation of Benlysta (belimumab) for Systemic Lupus Erythematosus

Posted 3 days ago in New Drug Approvals

London, UK 21 July 2017 -- GSK announced today that the US Food and Drug Administration (FDA) has approved a new subcutaneous formulation of Benlysta (belimumab) for the treatment of adult patients with active, autoantibody‑positive SLE who are receiving standard therapy. Systemic Lupus Erythematosus (SLE) is the most common form of lupus, a chronic, incurable autoimmune disease producing autoantibodies that can a...

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Merck Announces U.S. FDA Grants Tentative Approval for Lusduna Nexvue (insulin glargine injection), a Follow-On Biologic Basal Insulin

Posted 3 days ago in New Drug Applications

KENILWORTH, N.J.--(BUSINESS WIRE) July 20, 2017 --Merck (NYSE:MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has granted tentative approval for Lusduna Nexvue (insulin glargine injection) 100 units/mL, a follow-on biologic1 basal insulin in a pre-filled dosing device. Lusduna Nexvue is being developed by Merck with funding from Samsung...

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FDA Clears First Neonatal Magnetic Resonance Imaging Device

Posted 3 days ago in Pharma Industry News

July 20, 2017 -- Today, the U.S. Food and Drug Administration cleared the first magnetic resonance imaging (MRI) device specifically for neonatal brain and head imaging in neonatal intensive care units (NICU). “Although we can use traditional MRI scanners to image neonates, taking babies outside of the neonatal intensive care unit to MRI suites presents great challenges,” said Vasum Peiris, M.D., M.P.H., chief med...

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Churchill Pharmaceuticals Announces NDA Filing Acceptance for Yonsa by the U.S. FDA

Posted 4 days ago in New Drug Applications

KING OF PRUSSIA, Pa., July 20, 2017 /PRNewswire/ -- Churchill Pharmaceuticals, LLC (Churchill), a privately held company devoted to expanding treatment options with oral oncology agents, announces that the New Drug Application (NDA) for Yonsa™ (abiraterone acetate) ultramicrosize tablets has been accepted for filing by the U.S. Food and Drug Administration (FDA). Under the Prescription Drug User Fee Act (PDUFA), the ...

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Camurus and Braeburn Announce Submission of NDA for Long-Acting Buprenorphine (CAM2038) for Opioid Use Disorder

Posted 4 days ago in New Drug Applications

Lund, Sweden and Princeton, N.J. — July 20, 2017 — Camurus (NASDAQ STO: CAMX) and Braeburn Pharmaceuticals (“Braeburn”) today announced the completion of the rolling submission of the New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the approval of the companies’ weekly and monthly buprenorphine depots (CAM2038) as a treatment of opioid use disorder. Braeburn has also applied for Priority...

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FDA Accepts Biologics License Application for Aimovig (erenumab)

Posted 4 days ago in New Drug Applications

THOUSAND OAKS, Calif., July 20, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for Aimovig™ (erenumab) for the prevention of migraine in patients experiencing four or more migraine days per month. If approved, Aimovig is expected to be the first-and-only monoclonal antibody targeting the c...

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FDA Approves Vosevi (sofosbuvir/velpatasvir/voxilaprevir) for Re-Treatment of Adults with Chronic Hepatitis C Virus

Posted 5 days ago in New Drug Approvals

FOSTER CITY, Calif.--(BUSINESS WIRE)--Jul. 18, 2017-- Gilead Sciences, Inc. (NASDAQ: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved Vosevi (sofosbuvir 400 mg/velpatasvir 100 mg/voxilaprevir 100 mg) tablets, a single-tablet regimen for the re-treatment of chronic hepatitis C virus (HCV) infection in adults with genotype 1, 2, 3, 4, 5 or 6 previously treated with an NS5A...

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FDA Approves Nerlynx (neratinib) for Extended Adjuvant Treatment of Early Stage HER2-Positive Breast Cancer

Posted 6 days ago in New Drug Approvals

July 17, 2017 -- The U.S. Food and Drug Administration today approved Nerlynx (neratinib) for the extended adjuvant treatment of early-stage, HER2-positive breast cancer. For patients with this type of cancer, Nerlynx is the first extended adjuvant therapy, a form of therapy that is taken after an initial treatment to further lower the risk of the cancer coming back. Nerlynx is indicated for adult patients who have...

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Amgen and UCB Receive Complete Response Letter from U.S. FDA for Evenity (romosozumab) BLA

Posted 8 days ago in New Drug Applications

THOUSAND OAKS, Calif. and BRUSSELS, July 16, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and UCB (Euronext Brussels: UCB) today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter for the Biologics License Application (BLA) for Evenity™* (romosozumab) as a treatment for postmenopausal women with osteoporosis. The original submission included data from the pivotal Phase 3 p...

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Janssen Announces FDA Approval of Tremfya (guselkumab) for the Treatment of Moderate to Severe Plaque Psoriasis

Posted 10 days ago in New Drug Approvals

Horsham, PA, July 13, 2017 ― Janssen Biotech, Inc. (Janssen) announced today that the U.S. Food and Drug Administration (FDA) has approved Tremfya (guselkumab) for the treatment of adults living with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Tremfya is the first and only approved biologic therapy that selectively blocks only IL-23, a cytokine that plays a key role i...

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FDA Grants Full Approval for Blincyto (blinatumomab) to Treat Relapsed or Refractory B-cell Precursor Acute Lymphoblastic Leukemia in Adults and Children

Posted 13 days ago in New Drug Approvals

THOUSAND OAKS, Calif., July 11, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Blincyto (blinatumomab) to include overall survival (OS) data from the Phase 3 TOWER study. The approval converts Blincyto's accelerated approval to a full approval. The sBLA approval also included data from...

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Endo Provides Update On Opana ER

Posted 2 weeks ago in Pharma Industry News

DUBLIN, July 6, 2017 /PRNewswire/ -- Endo International plc (NASDAQ: ENDP) continues to believe in the safety, efficacy, and favorable benefit-risk profile of Opana ER (oxymorphone hydrochloride extended release) when used as intended, and notes that the Company has taken significant steps over the years to combat misuse and abuse. Nevertheless, after careful consideration and consultation with the FDA following...

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FDA Clears Expanded Use of Cooling Cap to Reduce Hair Loss During Chemotherapy

Posted 3 weeks ago in Pharma Industry News

July 3, 2017 -- Today, the U.S. Food and Drug Administration cleared the expanded use of a cooling cap, DigniCap Cooling System, to reduce hair loss (alopecia) during chemotherapy. This is the first cooling cap cleared by the agency for use in cancer patients with solid tumors. “We are pleased to expand the use of this product for cancer patients with solid tumors to potentially minimize chemotherapy-induced hair ...

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Monthly News Roundup - June 2017

Posted 3 weeks ago in Pharma Industry News

New Fluoroquinolone Baxdela Approved for Certain Skin Infections Roughly 3 million patients are hospitalized each year in the U.S. with acute bacterial skin and skin structure infections (ABSSSIs), some of which may be difficult-to-treat and show antibiotic resistance. In response, the FDA has approved Baxdela (delafloxacin), an oral and intravenous (IV) fluoroquinolone antibiotic. Baxdela targets both...

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FDA Allows Marketing of Test to Aid in the Detection of Certain Leukemias and Lymphomas

Posted 3 weeks ago in Pharma Industry News

June 29, 2017 -- The U.S. Food and Drug Administration today allowed marketing of ClearLLab Reagents (T1, T2, B1, B2, M), the first agency authorized test for use with flow cytometry to aid in the detection of several leukemias and lymphomas, including chronic leukemia, acute leukemia, non-Hodgkin lymphoma, myeloma, myelodysplastic syndrome (MDS) and myeloproliferative neoplasms (MPN). “This represents a major s...

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Incyte Announces First Patient Treated in Phase 3 Clinical Trial of Itacitinib for Acute Graft-Versus-Host Disease

Posted 4 days ago in Clinical Trials

WILMINGTON, Del.--(BUSINESS WIRE)--Jul. 20, 2017-- Incyte Corporation (Nasdaq:INCY) today announced that the first patient has been treated in GRAVITAS-301, a pivotal Phase 3 trial for the first-line treatment of patients with acute graft-versus-host disease (GVHD). The trial will evaluate the efficacy and safety of itacitinib, Incyte’s novel, potent, and selective JAK1 inhibitor, in combination with corticosteroids ...

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Kite Highlights Durable Complete Remissions Up to 56+ Months in Patients with Chemorefractory Aggressive Non-Hodgkin Lymphoma (NHL) after Anti-CD19 CAR T-Cell Therapy at the National Cancer Institute

Posted 4 days ago in Clinical Trials

SANTA MONICA, Calif.--(BUSINESS WIRE) July 20, 2017 -- Kite Pharma, Inc. (Nasdaq:KITE), a leading cell therapy company, highlighted the recent online publication of results in Molecular Therapy from a National Cancer Institute (NCI) study of anti-CD19 chimeric antigen receptor (CAR) T-cell therapy in patients with aggressive NHL including diffuse large B-cell lymphoma (DLBCL). The research, led by James N....

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U.S. FDA Grants Orphan-Drug Designation to Astellas for Development of FLT3 Inhibitor Gilteritinib in Acute Myeloid Leukemia

Posted 4 days ago in Clinical Trials

TOKYO, July 20, 2017 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, "Astellas") announced today that the U.S. Food and Drug Administration (FDA) granted orphan-drug designation to gilteritinib in patients with acute myeloid leukemia (AML). The Orphan Drug Designation program assigns status to drugs and biologics intended for the safe and effective treatment, diagnosis or...

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Aerie Pharmaceuticals Reports Positive Roclatan (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005% Phase 3 12-month Topline Safety Results

Posted 5 days ago in Clinical Trials

IRVINE, Calif.--(BUSINESS WIRE) July 19, 2017 -- Aerie Pharmaceuticals, Inc. (NASDAQ:AERI), a clinical-stage pharmaceutical company focused on the discovery, development, and commercialization of first-in-class therapies for the treatment of patients with glaucoma and other diseases of the eye, today reported the successful 12-month safety results of the Company's "Mercury 1" Phase 3 registration trial for its...

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Theravance Biopharma and Mylan Announce Positive Results from 12-Month Phase 3 Safety Study of Revefenacin (TD-4208) in Patients with Chronic Obstructive Pulmonary Disease (COPD)

Posted 5 days ago in Clinical Trials

DUBLIN, IRELAND, HERTFORDSHIRE, ENGLAND AND PITTSBURGH – July 19, 2017 – Theravance Biopharma, Inc. (NASDAQ: TBPH) ("Theravance Biopharma") and Mylan N.V. (NASDAQ, TASE: MYL) (“Mylan”) today announced positive results from a 12-month Phase 3 safety study of revefenacin (TD-4208), an investigational long-acting muscarinic antagonist (LAMA) and a proposed once-daily, nebulized bronchodilator in development for the trea...

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